MeningococcalPhase 4NCT02072525

A Protocol to Collect Human Serum Samples From Healthy Adults for Use as Quality Controls Samples in GlaxoSmithKline (GSK) Biologicals' Assays

A Phase 4 study testing Menveo®, Boostrix® and Pneumovax 23® in people with Meningococcal, run by GlaxoSmithKline at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to collect serum samples for use as quality control samples in GSK assays. The serum samples need to include samples with low, medium and high antibody titers/concentrations, which cover the assay range. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Meningococcal
What is being tested?: Menveo®, Boostrix® and Pneumovax 23®
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 359 participants
Where: 1 siteCanada
Study dates: 1 Apr 2014to 2 Jun 2015
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
A male or female between, and including, 18 and 55 years of age at the time of the first vaccination.
Written informed consent obtained from the subject.
Healthy subjects as established by medical history and clinical examination before entering into the study, with no medical conditions that in the opinion of the investigator prevents the subject from participating in the study.
Subjects must weigh at least 110 pounds (50 kg).
Female subjects of non-childbearing potential may be enrolled in the study.

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Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause.
Female subjects of childbearing potential may be enrolled in the study, if the subject:
has practiced adequate contraception for at least 30 days prior to vaccination, and
has a negative pregnancy test on the day of vaccination, and
has agreed to continue adequate contraception for the entire duration of the subject's participation in the trial.

Who cannot join

Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the dose of study vaccine, or planned use during the study period.
Subjects seropositive for hepatitis B surface antigen (HBsAg), antibody to hepatitis C virus (anti-HCV) or HIV.
Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose. Inhaled and topical steroids are allowed.
Administration of long-acting immune-modifying drugs at any time during the study period.
Any antibiotic taken during the period from 14 days before the collection of plasma up to the day of collection of plasma.
Any medication based on methyl phenidate HCL such as Metadate® or Concerta® or other CNS stimulants used to treat attention-deficit disorder or attention-deficit hyperactivity disorder taken during the period of 14 days before the collection of plasma up to the day of collection of plasma.

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Subjects who donated >500 mLs of blood within 60 days prior to any plasma collection visits (plasmapheresis).
Subjects who lost >200 mL of red blood cells during a single apheresis procedure or lost red blood cells on more than one occasion during apheresis within the previous 60 days.
Ongoing anemia as indicated by either (i) hemoglobin values, (ii) serum ferritin, or (iii) hematocrit values below the lower limit of the laboratory-specified reference range. If the laboratory results demonstrate an anemia, no further protocol procedures will be performed, and the subject will be referred for appropriate medical management. The subject may participate in this study following therapy and evidence that the anemia has been resolved.
Bleeding disorder and/or a clinical laboratory platelet count value below the lower limit of the laboratory-specified reference range.
Planned administration/administration of a vaccine not foreseen by the study protocol within the period starting 30 days before and 30 days after the dose of vaccine, with the exception of licensed inactivated influenza vaccine.
Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product.
Family history of congenital or hereditary immunodeficiency.
History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s).
Hypersensitivity to latex.
Serious chronic illness.
Acute disease and/or fever at the time of vaccination (Day 0).
Fever is defined as temperature ≥ 37.5°C /99.5°F for oral, axillary or tympanic route, or ≥ 38.0°C /100.4°F on rectal route. The preferred route for recording temperature in this study will be oral.
Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator.
Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
History of chronic alcohol consumption and/or drug abuse.
Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
Pregnant or lactating female.
Female planning to become pregnant or planning to discontinue contraceptive precautions.
Any confirmed or suspected immunosuppressive or immunodeficient condition (congenital or secondary) based on medical history and history directed physical examination (no laboratory testing at the screening visit is required).
Additional exclusion criteria for subjects 18-49 years of age
Previous vaccination against diphtheria and/or tetanus within the past 5 years and/or Neisseria meningitidis since birth.
Progressive neurological disorders, including uncontrolled epilepsy or progressive encephalopathy.
Subjects who have experienced an encephalopathy of unknown etiology, occurring within 7 days following previous vaccination with a pertussis containing vaccine.
Subjects who have experienced transient thrombocytopenia or neurological complications following an earlier immunization against diphtheria and/or tetanus.
If any of the following events had occurred in temporal relation to previous administration of whole-cell DTP or acellular DTP vaccine:
Temperature of ≥ 40.0°C within 48 hours of vaccination, not due to another identifiable cause.
Collapse or shock like state (hypotonic hyporesponsive episode) within 48 hours of vaccination.
Persistent, inconsolable crying lasting ≥ 3 hours, occurring within 48 hours of vaccination.
Convulsions with or without fever, occurring within 3 days of vaccination.
Additional exclusions criterion for subjects 50-55 years of age
Previous vaccination against Streptococcus pneumoniae.

Trial locations and contacts

1 site in 1 country.

Canada1 site

GSK Investigational Site
Sherbrooke, Quebec, J1H 2G2

Other trials in Canada

About this study

Official title: A Protocol to Collect Human Serum Samples From Healthy Adults

Read the detailed description

The purpose of this protocol is to source human serum from plasma from healthy adults for use as control samples in the assays supporting the clinical development of GSK Biologicals' vaccines for the prevention of invasive infections caused by Neisseria meningitidis, Streptococcus pneumoniae, Corynebacterium diphtheriae, Clostridium tetani and Bordetella pertussis. At the final visit, a small volume of whole blood will be obtained in addition to plasma, to allow for head to head comparison of serum obtained from whole blood (off-clot serum) and from plasma (serum derived from re-calcified plasma). In addition, sera generated in this clinical trial could potentially be used as control samples for other vaccine programs to help assure the quality of the analytical methods.

Subjects 18 through 49 years of age (have not yet achieved 50th birthday) will be randomized to receive Menveo + Boostrix and subjects 50 to 55 years of age will be randomized to receive either Pneumovax 23 or Prevnar 13 and will serve as donors of human serum in this study.

Conditions: Meningococcal
Being tested: Menveo®, Boostrix®, Pneumovax 23®, Prevnar 13®
Keywords: Pertussis, Healthy adults, Tetanus, Human serum samples, Streptococcus, Diphtheria, Plasma, Meningococcus
Medical subject headings: Whooping Cough, Tetanus, Diphtheria

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Menveo®Biological
One dose administered intramuscularly (IM) in the upper left deltoid of the arm.
Boostrix®Biological
One dose administered intramuscularly (IM) in the upper right deltoid of the arm.
Pneumovax 23®Biological
One dose administered intramuscularly (IM) in the non-dominant deltoid of the arm.
Prevnar 13®Biological
One dose administered intramuscularly (IM) in the non-dominant deltoid of the arm.

Study groups in NCT02072525
Study group	Role	What they receive
Mtdap1 Group	Experimental	Subjects will receive concomitant doses of Menveo and Boostrix. Receives: Biological: Menveo®; Biological: Boostrix®
Mtdap2 Group	Experimental	Subjects will receive concomitant doses of Menveo and Boostrix. Receives: Biological: Menveo®; Biological: Boostrix®
Mtdap3 Group	Experimental	Subjects will receive concomitant doses of Menveo and Boostrix. Receives: Biological: Menveo®; Biological: Boostrix®
Pneum1 Group	Experimental	Subjects will receive a dose of Pneumovax 23. Receives: Biological: Pneumovax 23®
Pneum2 Group	Experimental	Subjects will receive a dose of Pneumovax 23. Receives: Biological: Pneumovax 23®
Pneum 3 Group	Experimental	Subjects will receive a dose of Pneumovax 23. Receives: Biological: Pneumovax 23®
Prev1 Group	Experimental	Subjects will receive a dose of Prevnar 13. Receives: Biological: Prevnar 13®
Prev2 Group	Experimental	Subjects will receive a dose of Prevnar 13. Receives: Biological: Prevnar 13®
Prev3 Group	Experimental	Subjects will receive a dose of Prevnar 13. Receives: Biological: Prevnar 13®

What is being measured

The primary outcome is the main question the study is designed to answer.

Collection of human plasma for conversion into serum.
Collection of human plasma for conversion into serum for use as control samples in GSK Biologicals' assays in support of Neisseria meningitidis, Streptococcus pneumoniae, Corynebacterium diphtheriae, Clostridium tetani and Bordetella pertussis vaccine development programs.
Measured: At Visit 2 (Day 0).
Collection of human plasma for conversion into serum.
Collection of human plasma for conversion into serum for use as control samples in GSK Biologicals' assays in support of Neisseria meningitidis, Streptococcus pneumoniae, Corynebacterium diphtheriae, Clostridium tetani and Bordetella pertussis vaccine development programs.
Measured: At 10 days post-vaccination.
Collection of human plasma for conversion into serum.
Collection of human plasma for conversion into serum for use as control samples in GSK Biologicals' assays in support of Neisseria meningitidis, Streptococcus pneumoniae, Corynebacterium diphtheriae, Clostridium tetani and Bordetella pertussis vaccine development programs.
Measured: At 30 days post-vaccination.
Collection of human plasma for conversion into serum.
Collection of human plasma for conversion into serum for use as control samples in GSK Biologicals' assays in support of Neisseria meningitidis, Streptococcus pneumoniae, Corynebacterium diphtheriae, Clostridium tetani and Bordetella pertussis vaccine development programs.
Measured: At 60 days post-vaccination.
Collection of human plasma for conversion into serum.
Collection of human plasma for conversion into serum for use as control samples in GSK Biologicals' assays in support of Neisseria meningitidis, Streptococcus pneumoniae, Corynebacterium diphtheriae, Clostridium tetani and Bordetella pertussis vaccine development programs.
Measured: At 120 days post-vaccination

Secondary outcomes (1)

Occurrence of serious adverse events related to vaccination and to lack of vaccine efficacy throughout the study.
Measured: Throughout the study (Day 0 to Day 30 - Day 180).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Apr 20142 Jun 2015

First posted26 Feb 2014 (estimated)
Study start1 Apr 2014
Primary completion2 Jun 2015
Study completion2 Jun 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for MeningococcalStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 359 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02072525
Sponsor's protocol ID: 200612
Status last verified: Nov 2017
First submitted: 20 Feb 2014
Last updated: 27 Nov 2017
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Single-center, Open-label Study: Immunogenicity and Safety Observation After Vaccination With ACYW135 Meningococcal Polysaccharide Vaccine in Junior High School Students Aged 13-15 Years
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Immunogenicity and Safety Study of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered in Healthy Infants and Toddlers in China
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Active, not recruitingPhase 2
Safety, Tolerability, and Immunogenicity of MenABCWY Administered on Different Dosing Schedules in Healthy Adolescents
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Active, not recruitingPhase 3
Study on an Investigational Quadrivalent Meningococcal Conjugate Vaccine (MenACYW Conjugate Vaccine) Administered as a 5- and/or 10-year Booster Doses in Children and Adolescents Vaccinated 5 or 10 Years Earlier as Toddlers
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All Meningococcal trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Protocol to Collect Human Serum Samples From Healthy Adults
ClinicalTrials.gov ID: NCT02072525
Acronym / sponsor ID: 200612
Conditions: Meningococcal
Keywords: Pertussis, Healthy adults, Tetanus, Human serum samples, Streptococcus, Diphtheria, Plasma, Meningococcus
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 359 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 1 Apr 2014 (actual)
Primary completion: 2 Jun 2015 (actual)
Study completion: 2 Jun 2015 (actual)
First posted: 26 Feb 2014 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 9

Arm	Type	Receives
Mtdap1 Group	Experimental	Biological: Menveo®, Biological: Boostrix®Subjects will receive concomitant doses of Menveo and Boostrix.
Mtdap2 Group	Experimental	Biological: Menveo®, Biological: Boostrix®Subjects will receive concomitant doses of Menveo and Boostrix.
Mtdap3 Group	Experimental	Biological: Menveo®, Biological: Boostrix®Subjects will receive concomitant doses of Menveo and Boostrix.
Pneum1 Group	Experimental	Biological: Pneumovax 23®Subjects will receive a dose of Pneumovax 23.
Pneum2 Group	Experimental	Biological: Pneumovax 23®Subjects will receive a dose of Pneumovax 23.
Pneum 3 Group	Experimental	Biological: Pneumovax 23®Subjects will receive a dose of Pneumovax 23.
Prev1 Group	Experimental	Biological: Prevnar 13®Subjects will receive a dose of Prevnar 13.
Prev2 Group	Experimental	Biological: Prevnar 13®Subjects will receive a dose of Prevnar 13.
Prev3 Group	Experimental	Biological: Prevnar 13®Subjects will receive a dose of Prevnar 13.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (11 listed)

Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
A male or female between, and including, 18 and 55 years of age at the time of the first vaccination.
Written informed consent obtained from the subject.
Healthy subjects as established by medical history and clinical examination before entering into the study, with no medical conditions that in the opinion of the investigator prevents the subject from participating in the study.
Subjects must weigh at least 110 pounds (50 kg).

Key exclusion criteria (37 listed)

Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the dose of study vaccine, or planned use during the study period.
Subjects seropositive for hepatitis B surface antigen (HBsAg), antibody to hepatitis C virus (anti-HCV) or HIV.
Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose. Inhaled and topical steroids are allowed.
Administration of long-acting immune-modifying drugs at any time during the study period.
Any antibiotic taken during the period from 14 days before the collection of plasma up to the day of collection of plasma.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Menveo®One dose administered intramuscularly (IM) in the upper left deltoid of the arm.	Biological	Mtdap1 Group, Mtdap2 Group, Mtdap3 Group
Boostrix®One dose administered intramuscularly (IM) in the upper right deltoid of the arm.	Biological	Mtdap1 Group, Mtdap2 Group, Mtdap3 Group
Pneumovax 23®One dose administered intramuscularly (IM) in the non-dominant deltoid of the arm.	Biological	Pneum 3 Group, Pneum1 Group, Pneum2 Group
Prevnar 13®One dose administered intramuscularly (IM) in the non-dominant deltoid of the arm.	Biological	Prev1 Group, Prev2 Group, Prev3 Group

Primary outcome

Collection of human plasma for conversion into serum.
Time frame: At Visit 2 (Day 0).
Collection of human plasma for conversion into serum for use as control samples in GSK Biologicals' assays in support of Neisseria meningitidis, Streptococcus pneumoniae, Corynebacterium diphtheriae, Clostridium tetani and Bordetella pertussis vaccine development programs.
Collection of human plasma for conversion into serum.
Time frame: At 10 days post-vaccination.
Collection of human plasma for conversion into serum for use as control samples in GSK Biologicals' assays in support of Neisseria meningitidis, Streptococcus pneumoniae, Corynebacterium diphtheriae, Clostridium tetani and Bordetella pertussis vaccine development programs.
Collection of human plasma for conversion into serum.
Time frame: At 30 days post-vaccination.
Collection of human plasma for conversion into serum for use as control samples in GSK Biologicals' assays in support of Neisseria meningitidis, Streptococcus pneumoniae, Corynebacterium diphtheriae, Clostridium tetani and Bordetella pertussis vaccine development programs.
Collection of human plasma for conversion into serum.
Time frame: At 60 days post-vaccination.
Collection of human plasma for conversion into serum for use as control samples in GSK Biologicals' assays in support of Neisseria meningitidis, Streptococcus pneumoniae, Corynebacterium diphtheriae, Clostridium tetani and Bordetella pertussis vaccine development programs.
Collection of human plasma for conversion into serum.
Time frame: At 120 days post-vaccination
Collection of human plasma for conversion into serum for use as control samples in GSK Biologicals' assays in support of Neisseria meningitidis, Streptococcus pneumoniae, Corynebacterium diphtheriae, Clostridium tetani and Bordetella pertussis vaccine development programs.

1 secondary outcome

Occurrence of serious adverse events related to vaccination and to lack of vaccine efficacy throughout the study.
Time frame: Throughout the study (Day 0 to Day 30 - Day 180).

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2017.
GSK-CSR CTRS PDF link given.Link provided by the sponsor.

Related trials for Meningococcal

Not yet recruitingPhase 4
Single-center, Open-label Study: Immunogenicity and Safety Observation After Vaccination With ACYW135 Meningococcal Polysaccharide Vaccine in Junior High School Students Aged 13-15 Years
Meningococcal Disease; Meningococcal Meningitis
RecruitingPhase 3
Immunogenicity and Safety Study of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered in Healthy Infants and Toddlers in China
Meningococcal Infection, Healthy Volunteers
Active, not recruitingPhase 2
Safety, Tolerability, and Immunogenicity of MenABCWY Administered on Different Dosing Schedules in Healthy Adolescents
Meningitis, Meningococcal
Active, not recruitingPhase 3
Study on an Investigational Quadrivalent Meningococcal Conjugate Vaccine (MenACYW Conjugate Vaccine) Administered as a 5- and/or 10-year Booster Doses in Children and Adolescents Vaccinated 5 or 10 Years Earlier as Toddlers
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RecruitingObservational study
A Study to Learn About the Safety of PENBRAYA During Pregnancy
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Menveo®, Boostrix® and Pneumovax 23® in people with Meningococcal, run by GlaxoSmithKline at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 37 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Collection of human plasma for conversion into serum. (time frame: At Visit 2 (Day 0).). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02072525.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2017.